2011 US FDA orphan drug designations

Pharmaceutical companies turn to orphan drug development, a viable alternative to what one quipped as the death of blockbuster drugs.

Applications for orphan drug designations have been climbing nationwide in recent years. In 2010, the U.S. Food and Drug Administration’s Office of Orphan Products Development received 323 applications and approved 14 orphan drugs. In 2009, there were 250 applications and 17 approvals. Triangle Business Journal, July 22, 2011